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安全审查简介 Introduction of Safety Review 拜耳医药保健有限公司北京工厂 BHC Product Supply Beijing Site 2012 年 3 月 March, 2012. 内容 Content. 拜耳集团工艺与工厂安全规范 Bayer Group Process and Plant Safety Regulations 安全概念 的建立 Development of Safety Concept s 安全审查的程序 Procedures of Safety Review 降低风险的基本原理

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  1. 安全审查简介Introduction of Safety Review拜耳医药保健有限公司北京工厂BHC Product Supply Beijing Site2012年3月March, 2012

  2. 内容Content • 拜耳集团工艺与工厂安全规范 Bayer Group Process and Plant Safety Regulations • 安全概念的建立 Development of Safety Concepts • 安全审查的程序 Procedures of Safety Review • 降低风险的基本原理 Basic Principles to Reduce Risk Introduction of Safety Review • Page 2 •March, 2012

  3. 拜耳集团工艺与工厂安全规范 Bayer Group Process and Plant Safety Regulations 政策方针 Policy Bayer集团工艺及工厂安全 Process & Plant Safety in the Bayer Group 集团规定No. 2020 Group Regulation No. 2020 生效日期: 2010年4月1日 Effective: April 1, 2010 指令 Directive 工艺及工厂安全 Process and Plant Safety 集团规定No. 13-1 Group Regulation No. 13-1 生效日期: 2004年10月1日 Effective: October 01, 2004 操作规程 Procedure 厂房、设备及公用系统的安全状态回顾 Safety Status Review for Facilities, Equipment and Systems标准操作规程 S 25-046 SOP S 25-046 生效日期：2010年3月29日 Effective: March 29, 2010 导则 Guideline 工艺及工厂安全纲要 Process and Plant Safety Compendium 集团规定No. 1928 Group Regulation No. 1928 生效日期：2007年7月1日 Effective: July 01, 2007

  4. 工艺及工厂安全指令和标准操作规程 Directive and SOP of Process and Plant Safety • 安全概念 • Safety concept • 工作流程 (含各级证书) • Work flow (with certificates) • 初步安全分析 (A1) • Preliminary Safety Analysis (A1) • 基础安全审查 (A2) • Basic Safety Review (A2) • 详细安全审查 (A3) • Detailed Safety Review (A3) • 开车前安全审查 (A4) • Pre Start-Up Safety Review (A4) • 角色和职责 • Roles and responsibilities For Reference Directive Process & Plant Safety 对于每个工艺和工厂，安全概念必须建立、存在。 For every process and plant a safety concept must be developed and in place

  5. 工程 / 运行前阶段 Engineering / Start-up-Phase 实施 Do 计划 Plan 检查 Check 行动 Act 生产 / 运行阶段 Production / Operation-Phase 安全概念的建立 Developmentof Safety Concepts A1, A2, A3 计划 Plan 实施 Do A3-R A4 检查 Check 行动 Act R =重新评估 R = Revalidation A4-R

  6. 安全审查的程序Procedures of Safety Review A1初步安全分析 A1 Preliminary Safety Analysis 随着项目的进展，对安全设计概念进行逐步的，细化的安全评估。 Stepwise review of safety concepts with increasing detailed investigation during the developing of project phases. A2 基本安全审查 A2 Basic Safety Review A3 详细安全审查 A3 Detailed Safety Review A4 运行前的安全审查 A4 Pre Start-Up Safety Review 重新评估 Revalidation

  7. 工作步骤：A1 初步安全分析Work Stage: A1 Preliminary Safety Analysis A1审查阶段 Review Stage A1 • 安全数据的编辑和评估compilation and evaluation of safety data • 检查，提出本质安全设计的建议 • examination, proposals for inherent safer design • 检查可选的安全概念 • check of alternative safety concepts 初步安全分析证书： Preliminary Safety Analysis Certificate: 在项目投资预批准之前获得 For projects prior to Invest Pre-Approval

  8. 工作步骤： A2 基础安全审查Work Stage: A2 Basic Safety Review A2审查阶段 Review Stage A2 • 建立基本的安全概念 • develop the basic safety concept • 使用检查表 • using checklists 基础安全审查证书： Basic Safety Review Certificate: 在提交许可申请或者拨款申请前获得 Prior to the submission of permit application or appropriation request

  9. 工作步骤： A3 详细安全审查Work Stage: A3 Detailed Safety Review A3审查阶段 Review Stage A3 • 系统地辨识危害 • systematic identification of the hazards • 风险评估 • risk assessment • 确定适当的安全措施 • definition of adequate preventive and mitigating safety measures 详细安全审查证书 Detailed Safety Review Certificate: 在采购之前获得 Prior to the procurement of plant components

  10. 工作步骤：A4 运行前安全审查Work Stage: A4 Pre Start-Up Safety Review A4 审查阶段 Review Stage A 4 • 检查在A3中提到的要求是否实现以及工厂是否按照之前讨论的结果来建设 • checked whether all required defined measures which were specified in the detailed safety review (A3) have been realized and the plant is build as discussed • 检查，检查及功能性测试 • plant inspections, checks • and functional equipment testing 运行前安全审查证书 Pre Start-Up Safety Review Certificate: 在运行前获得 Prior to start up of the plant

  11. 生产 / 操作 Production / Operation 工作步骤：定期再评审Work Stage: Periodic Review 在最近一次A3评审的5年之内 within 5 years after last A3 开车 Start Up 项目 Project 重大的 Significant 变更 Modifications minor /simple 小的 / 简单的 A1 当前的安全评审文件 Current Safety Review Document 安全概念再评审 Revalidation of Safety concept A2 变更管理 MoC A3 A4 A4 A4-R A3-R MoC= 变更管理 MoC= Management of change R =重新评估的 R = Revalidation

  12. 安全审查参与成员Participants of Safety Reviews 团队核心 Core-Team 工厂/部门PLANT/UNIT 工程人员 Plant Engineering 维修人员 Maintenance 生产人员 Production 过程控制工程师 Process Control Engineering 法规事务 Regulatory Affairs SafetyReview 安全评审 项目工程师 Project Engineering 消防 Fire Prevention 工艺安全工程师 Process and Plant Safety 职业安全 Occupational Plant Safety 环境保护 Environmental Protection 技术检查 Technical Inspection 同一人员也可能会同时担任多个角色 Several functions may be assumed by a same person

  13. 安全审查文件的重要性Safety Review Documentation • 安全审查的相关文件是工艺和工厂方面信息的最重要来源。它确保下列工作安全并且正确地执行： The safety review documentation is one of the most important sources of information for a specific process or plant. It makes it possible to safely and correctly perform tasks such as: • 预防性维护 • Preventive maintenance • 故障应急维护 • Emergency maintenance and breakdowns • 过程变更 • Process changes • 员工培训 • Employee training • 按照法律要求准备和更新安全报告 • Preparation and updating of safety reports in compliance with legal requirements.

  14. 降低风险的基本原理 Basic Principles to Reduce Risk 1. 消除危害或者将潜在的危害最小化 Eliminate or minimize potential hazard 2. 避免失误或者将潜在的失误降到最低 Avoid or Minimize potential failures 3. 把工艺或过程设计成失误-可接受 Design processes and plants to be fault-tolerant 4.减轻可能的事件的影响 Mitigate the effects of potential incidents 风险= 结果的严重程度 x 事件发生的可能性 Risk = Consequence Severity x Event Frequency

  15. D C B A F D C B F E D F F F F E 严重性表Severity Tables 频率表Frequency Tables 降低风险-工作流程Reduce Risk-Work Flow 风险降低 Risk reduction 详细的安全措施 Specification of safety measures 风险评估 Risk assessment 后果的严重性 Severity of consequences 情景发生的频率 Frequency of scenario 危险识别 Hazard identification 安全措施工具箱 Measure tool box 可能的风险 Scenarios 用风险矩阵鉴定风险级别 Identification of risk class with risk matrix 严重性Severity 频率Frequency

  16. 风险分析文件的结构Hazard Analysis Document Structure • 工艺描述DESCRIBE THE PROCESS • 物质的描述和特性 DESCRIBE AND CHARACTERIZE THE SUBSTANCES • 通过下面方法进行风险评估 EVALUATE THE RISK VIA • HAZOP / FMEA = 评估可能性 HAZOP / FMEA = ESTIMATE THE PROBABILITY (P) • 结果分析= 评估严重程度CONSEQUENCE ANALYSIS = ESTIMATE HOW BIG THE PROBLEM IS (E) • RISK R = P x E • 控制风险的措施 COUNTERMEASURES TO CONTROL THE RISK • 确定剩余的风险 DEFINE THE RESIDUAL RISK • 风险分析评估地点的分类CLASSIFY THE PLACE WHERE THE RISK IS EVALUATED • 爆炸环境(燃烧/爆炸） ATEX (FLAME/EXPLOSION) • 噪声NOISE • 生物的/致突变的/致癌的 BIOLOGICAL/MUTAGENIC/CANCEROGENIC • 机械的 MECHANICAL • 建立系统来控制危险 SET UP A SYSTEM TO CONTROL THE DANGER • 检查WALKTHROUGH • 提高意识/培训 AWARENESS / TRAININGS

  17. 谢谢！ Thank you!

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